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From the 6/11/2021 release of VAERS data:

This is VAERS ID 181698

Case Details

VAERS ID: 181698 (history)  
Form: Version 1.0  
Age: 51.0  
Sex: Female  
Location: Rhode Island  
   Days after vaccination:24
Submitted: 2002-10-02
   Days after onset:1237
Entered: 2002-02-26
   Days after submission:217
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Private       Purchased by: Private
Symptoms: Amnesia, Arthralgia, Arthropathy, Back pain, Crohn's disease, Disturbance in attention, Gastrointestinal disorder, Infection parasitic, Injection site pain, Neck pain, Pain, Pyrexia, Serum sickness, Thrombosis, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal premalignant disorders (narrow), Thrombophlebitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Ischaemic colitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ferrous sulfate; progesterone; thyroxine sodium; vitamin E; ascorbic acid
Current Illness: UNK
Preexisting Conditions: Her family history includes four brothers w/o any thrombosis. The mother has no thromobotic history. The father has no thrombotic history but died of coronary disease at 42. Autns, uncles and grandparents include multiple individuals with heart disease in there (sic) 80s and 90s. The children are health. She does have one daughter who was some hypochdriasis. There is no history of multiple miscarriage or very earl deaths." *Follow-up on 10/10/02: Chronic sinusitis, deviated nasal septum, streee.
Diagnostic Lab Data: Albumin serum 2.5g/dL 7/21/99; antimitochondrial antibody <1:20 6/19/00; antinuclear antibody 1:80 7/3/00, homogeneous 7/3/00, 1:320 7/6/00; antiamoothmuscle antibody <1:20 6/4/00; antithrombin IIII 106%; erythrocyte sed rate 120mm/hr 7/1/99, 35mm/hr 6/19/00, 65mm/hr 7/6/00, 48mm/hr 7/5/01, 52mm/hr 8/23/01; G. glutamyl transferase serum 59U/L 7/1/00; HLA-B27 positive 7/6/00; hep B surface antibody positive 6/4/00, hep B surface antigen negative 6/4/00; hep C antibody negative 6/4/00; RA titer <20mm/hr 6/19/00; SGOT 47U/L 6/19/00, 82U/L 7/1/00, 63U/L 7/6/00; SGPT 97U/L 6/19/00, 134U/L 7/1/00, 83U/L 7/6/00; white blood cell count 13,800/cu mm 7/1/99. Electrocardiogram 7/22/99: normal sinus rhythm with an RSR prime conduction delay and electrocardiogram with right sided leads revealed no elevation in lead V4R. Echocardiogram 7/22/99: normal left ventricular function, moderate right ventricular dysfunction, moderate to severe tricuspid regurgitation and no evidence of aortic insufficiency, mitral regurgitation or pericardial effusion. VQ scan 7/22/99: patchy perfusion with only some segmental defects. Transesophageal echocardiogram 7/22/99: adherent thrombus in the right ventricle. There is also a significant RV dilation and RA dilation with RV hypokinesis. Esophagogastroduodenoscopy 9/30/99: erosive duodentitis at the junction between the first and second portion of the duodenum. Diffuse chronic gastritis. Normal esophagus. Total colonoscopy to the terminal ileum 9/30/99: moderately severe colitis. Severe terminal ileisis. Biopsies of antrum, gastric body, duodenum, terminal ileum, right colon, transverse colon, left colon, rectum 9/30/99: changes from the terminal ileum to left colon are consistent with chronic active IBD with involvement of the gastric antrum and possibly first portion of the duodenum. Rectim is relatively spared. No dysplasia is seen. Small bowel x-ray series with contrast 10/20/99: impression-moderate to severe abnormality of the distal 30 to 35cm of the ileum consistent with Crohn''s disease. No ulceration, stricture or fistula formation identified. Total colonoscopy to the terminal ileum 3/31/00: rectum, colon and terminal ileum were all completely healed. There were only a few areas of very subtle scarring in the signoid colon with slight distortion of the vascular pattern, but no active Crohn''s disease. No stricture. Lyme IgG western blot 7/8/00: 20, 23, 31, 24kD bands present. Lyme IgM western blot, 7/5/00: 31kD band present. Esophagogastroduodenoscopy 11/15/01: esophagus was normal. Stomach-antrum with minimal erythema, no erosioins or ulcerations. Multiple biopsies were obtained to rule out H. pylori. The gastric body, cardia and fundus were all normal. The duodenum was normal to the second protion. The previously seen inflammatory bowel disease was no longer present. Total colonoscopy to the terminal ileum 11/15/01: terminal ileum-involved with circumferential fibrin based ulcerations. There was no stricture. The proximal right colon was ulcerated with normal intervening mucose. There was slight mottling and very subtle ulcerations around the transverse colon and a few in the left colon. Rectum normal. Impression: recurrent Crohn''s disease. Biopsies of antrum, terminal ileum, random colon 11/15/01: colonic biopsies and biopsy of ileum show active chronic inflammatory bowel disease and focal ulceration in the ileum consistent with Crohn''s ileocolitis. No dysplasia is noted. *Follow-up report on 10/10/02: Folate, 3/14/02, result 14.5 ng/mL, range 2.0-16/0; Lyme IgA, EIA, 6/27/00, result <1; Lyme IgG, EIA, 6/27/00, result <1;Lyme IgM, EIA, 6/27/00, result <1; WNF antibody, 8/3/00, result Neg; Sjogren''s SS-A antibody, 8/3/00, result Neg; Sjogren''s SS-B antibody, 8/3/00, result Neg; Smith antibody, 8/3/00, result Neg; Thyroid paroxidase antibody, 2/28/02, result $g 70IU/mL, range 0-2; Vitamin B12, 3/14/02, result $g2000 pg/mL, range 150-950. Transenoptageal echocardiogram, 7/22/99: "CONCLUSION: 1) Normal left ventricular size and systolic function. 2) Right atrial and right ventricular enlargement w/right ventricle hypokinesia and mobile chrombus noted in the right ventricle. 3) Severe tricuspid regurgitation w/pulmonary hypertension." Bilateral lower extremity venous ultrasound, 7/23/99: "CONCLUSION: No evidence of venous thrombosis involving either lower extremity." CT chest, 7/23/99: "Impression: 1) moderate bilateral ploural effusions with bibasillar consolidation and smaller patchy areas of consolidation in each upper lobe. The focus in the periphery of the left upper lobe does have a somewhat rounded configuration and an evolving pulmonary infarct cannot be excluded. 2) Evidence of thrombus in the superior vena cava." MRI Chest, 7/24/99: "Impression: No evidence of thrombus or tumor w/in the superior vena cava. The right atrium and right ventricle are less well visualized, however, no filling defects are deomnstrated at these levels". MRI cardiac, 7/26/99: "Impression: There is a linear structure noted w/in the right ventricle which may correlate w/the findings seen on echocardiography. No rounded or mass-like intraventricular lesioin is seen. 2) Area of questionable thickening along the tricuspid valve. This may very well be secondary to turbulent flow, however recommend correlation w/the findings on the recently performed transesophageal echocardiogram". Transosophageal echocardiogram, 7/26/99: "Conclusion: 1) Normal left ventricular systolic function. 2) Significant right ventricular thickening of the valvular apparatus extending to the ventricular wall. The differential diagnosis includes a normal variant w/significant thickening; however, a thrombi and tumor are also in the diffrential. 3) Mild trisuspid regurgitation w/out pulmonary hypertension." CT Chest and pulmonary arteries, 7/26/99: "Impression: No evidence of thrombus w/in the great vessels. Interval increase in bilateral pulmonary infiltrates w/in the upper lobe. These could be infectious due to septic or pulmonary emboli. Bilateral effusions, larger on the left than on the right". Lyme immunoblot, 6/27/00: 18, 29, 30, 31 kD bands present. X-rays hands, 7/7/00: "Impression: Intact bilateral hand series w/out visualized abnormality by plain film assessment." Lyme IgG Wester blot, 8/3/00: "Uninterpretable. Lyme vax interference. Unable to rule out Lyme disease on vax pt''s." Lyme IgG ELISA, 10/16/01: 160 (normal <80); Lyme IgG Western blot, 10/16/01, Negative, 31 kd band present; Lyme IgM Western blot, 10/16/01, Negative, zero band present; MarDX Western Blot IgG, 10/16/01: Negative, one unspecified band present; Immenetics Western blot IgG, 10/16/01, Negative, 23, 28, 41 kd band and five unspecified bands present;
CDC Split Type: A0359781A

Write-up: The pt reportedly received Lymerix; the number of injections administered was not reported. In a Statement of Injuries, her attorney alleged that the pt "suffers from arthropathy and aches in her ankles, shoulders, neck, lower back, hips, thighs and hand joints, thrombosis, persistent headaches and low-grade fevers, blurred vision and memory loss/difficulty concentrating. (She) also suffers from a Crohn''s disease-like auto-immune syndrome manifesting itself in an inflammatory bowel disease involving the stomach, duodenum, terminal ileum and entire colon". Time to onset following immunization, treatment and outcomes of the alleged events were not reported. Mecial records from a henatogolist, dated 6/22/01, indicated that the vaccinne "has a history of multisystem complaints, both neurologic and systemic. She tells me that this is thought to be in the aftermath of a Lyme vacine. The patient''s history is as follow: In april 1999 she had an elevated sed rate, six weeks later she devleoped a clot in the right rear vetricle of her heart. She had TPA (tissue plasminogen activator) therapy. She is under the impression that the clot dissolved. She was on Heparin and coumadin for a year and half. She took herself off the coumadin. It is my impression that some physicians thought she should go off coumadin and someth thought she should remain on. The patient is seeing (an infectious disease specialist). I subsequently discussed the case with (the infectious disease specialist) and she said that she had some thromboses occurring in the aftermath of Lyme vaccine. The patient has been pregnant four times, leading to three live births and one child who died with a congential anomaly. She has never had a miscarriage or a previous clot. She is being worked up for Lyme vaccine problems, Lyme and multiple sclerosis. Her family history includes four brothers w/o any thrombosis. The mother has no thromobotic history. The father has no thrombotic history but died of coronary disease at 42. Autns, uncles and grandparents include multiple individuals with heart disease in there (sic) 80s and 90s. The children are health. She does have one daughter who was some hypochdriasis. There is no history of multiple miscarriage or very earl deaths." The vaccinee returned to the hematologist on 7/10/01. She reported "that she recently had a flare of her Lyme syndrome. She took Remicade and feels better. She is also on some ? fish tablets for three weeks. She became better shortly after she started the remicade. In reviewing her history, she appears to have a clot in her heart. There is some disagreement still regarding this point but she does not appear to have any persistent thrombus. There was a possible second clot in the SVC (superior vena cava) and pulmonary artery but this was never confirmed. This also appears to be absent at this time. These both occurred in the setting of a multisystem disease this is probably related to the Lyme vaccine I told her I believe she has a very highly provoked clot. The vaccinee returned to the hematologist on 9/14/01. She reported that she "has had a yeast infection in her throat. She was referred here with a positive antiphospholipid antibody and lupus anticoagulant. She was also known to have an elevated Factor VIII level. Of note her repeat studies in June and July showed normal lupus anticoagulant and ? anticordiolipin antibody. She tells me ''negative genetic analysis for lupus'', told her that I suspect that her thrombosis occurred in the setting of inflammation. It is alos possible that the Factor VIII is a marker of increased susceptibility to thrombosis. It is unclear whether the Factor VIII will will remain elevated. As a result of her inflammatory state or wheter it will now return to normal. She is open to a strategy of intermittent coumadin use or lovenox use. the most recent information received on 5/14/02, indicated that the thrombosis resolved in 1999. Outcomes of the other reported events were not provided. Inflammatory bowel disease and thrombosis are considered "Medically Serious". The follow up states the report describes Crohn''s disease. The medical history included chhamydia infection, microscopic hematuria, hypercholesterolemia, cervical carcinoma in situ (1978), eczema, psoriasis, fatigue, urinary frequency and incontinence, and a 30 pack-year history of tobacco use. She reportedly stopped smoking in August 1999. Testing for HLA-B27 positive; testing was also reportedly positive for HLA-DR4. Family history was significant for inflammatory bowel disease (grandmother), premature coronary artery disease (father died of myocardial infarction at age 41, family members on father''s side had premature coronary artery disease), "thromboembolic problem" of the lower extremity (grandmother), asthma (brother and grandson), and goiter (aunt). Surgical history included bilateral tubal ligation (1979), cone biopsy of the cervix, and grafting for periodontal disease. Medications at the time of immunization were not specified. Following the reported onset of Crohn''s disease, the vaccinee experienced two episodes of "flu" and hypothyroidism. The vaccinee reportedly received three injections of LYMErix. She reported different dates of immunization to different physicians. She told one infectious disease specialist that she received two injections of LYMErix in March 1999, and one in May 2000; exact dates were not provided. She told another infectious disease specialist that she received LYMErix in 3/23/99, 4/20/99 and 5/30/99. She told a rheumatologist that she received LYMErix in March 99, April 99, and March 2000; exact dates were not provided. Records from the vaccine provider, that would clarify the dates of immunization, have not been forwarded by the vaccinee''s attorney. The vaccinee presented to a gastroentarologist on 5/14/99 "with multiple GI complaints. She carried a diary and described what has transpired with her heealth status and personal problems over the past year. In 9/98 her grandson, who had moved out of her home because of poly substance abuse, was in a car accident that resulted in partial amputation of his right arm, injury to his right eye and closed head injury. THis event caused a great deal of stress in her family. She also discovered that her husband was having an affair and she finally quit her job, where she had a boss who was constantly borating her. With all this stress, she developed "irritable bowel" with twenty loose stools per day, crrampy abdominal pain and excessive gas with loud bowel sounds. She had a long list of symptoms, including loss of focus, forgetfulness, change in spousal relationship, sleeping all day, waking up in the middle of the night with excessive gas and since 9/98, she has gained fifteen pounds. In February she was started on Zithromax for nasal congestion and a sore throat. She required multiple prescriptions for antibiotics to clear this infection. When questioned about her diet, pt did admit to ingesting a great deal of dairy products. She uses chocolate, milk, cream, yougurt and cottage cheese daily, a lot of butter and ice cream once a month. When questioned about what types of food precipitate problems, each and every one contained lactose. In fact she recently prresented to an ER with a severe attack of gas and cramps following the ingestion of creamy clam chowder, prime rib, garlic mashed potatoes with some type of cream sauce and bread and butter. Medications at the time of evaluation included vitamin B, "high dose" vitamin C, iron sulfate, Lomotil prescribed at the ER, and Compazine prescribed at the ER. Physical examination revealed "hyperactive bowel sounds." The abdomen was "soft, nontender." The gastroenterologist''s impression was "new onset of crampy abdominal pain, excessive gas, and frequent diarrhea. Pt states that she has replaced meat with dairy products. The onset of her symptoms correspondes to when she made this dietary change. Recommendations: I therefore suspect tha tmost, if not all, of her symptoms are secondary to lactose intolerance. Pt was given the usual recommendations for this problem." The vaccinee presented to the local ER on 7/21/99 "with six days of chest discomfort radiating across her substernal area, through to her shoulder blades, as well as up into the left neck and ear area. This waxed and waned, did not seem to get any worse with exertion, but had been associated with diaphoresis, dyspnea and exertion, and even shortness of breath at rest. She denied any recent palpitations. She denied any recent peripheral edema. She did note a respiratory infection approximately a week prior to this and had been on Zithromax for potential bronchitis after being sent to the hospital. She denied recent fevers, chills, change in bowel or bladder. She had some nausea but no vomiting. Past medical history: hypercholesterolemai. Status post bilateral tubal ligation. The The pt was admitted to the ICR, heparinized, given aspirin. Cardiac consultation was obtained. In the early morning hours the pt''s blood pressure dropped. She had been on some IV nitroglycerin which was discontinued. She was given fluid bolutes, but with failure to respond. Cardiology came in and did a bedside echocardiogram who demonstrated significant RV dysfunction with a question fo thrombus in the right ventricle. She was given TPA. There was a substantial improvement in the pt''s cardiac function over the next 12 to 24 hrs. The pt underwent transesophageal echocardiogram which continued to suggest the presence of an abnormality in the right ventricle. CT scan of the chest raised some question of extension of abnormality into the superior vena cava and into the pulmonary artery, but follow up studies could not substantiate this finding. She was maintained on heparin and eventually changed over to Coumadin. There was also a suggestion on CT of the possibility of pneumonia and she was started on antibiotics. This ultimately turned out to be some atypical pulmonary edema, probably relating to the fluid resuscitation, and this resolved rather promptly with diuresis. The pt eventually underwent MRI scanning of the heart to try to identify what had been suggested by transesophageal echocardiogram. A cardiac MRI demonstrated a tubular structure in the right ventricle of questionable etiology. Interestingly, a lung scan that was performed shortly after the diagnosis of thrombus was of low probability. Follow up TSE demonstrated resolution of the thrombus. Chest films normalized. The pt''s prothrombin time became therapeutic and it was felt that she could be safely discharged to home on 7/30/99." She was actually discharge don 7/31/99. Discharge diagnosis were "right ventricular thrombus. Pulmonary embolus. Respiratroy insufficiency. Right ventricular abnormality of questionale etiology. Hypoalbuminemia." Discharge medications included Coumadin 5mg daily, Zithromaz 500mg for one day then 250mg dialy for four days, Augmentin 875mg twice daily for five days, Feosol 325mg twice daily for 30 days, and progesterone cream 0.25mg twice daily. The vaccinee returned to the gastroenterologist on 9/17/99 "with a chief complaint of who has turned against me." She states that hse has lost 20 pounds since the sping. She has noticed undigested french fries and oranges along with red peppers and celary in her stool, and believes she is not absorbing nutrients. Impression: weight loss with visualized food particles in stool. This suggests pancreatic maldigestion or small bowel malabsorption. Recommendations: trial of Pancrease with meals and snacks to determine if maldigestion is playing a role. D-xylose test to tell if the small bowel is absorbing properly." The vaccinee was hospitalized by the gastroenterologist on 9/30/99 to undergo endoscopy wiht small bowel biopsy and duodenal aspirate, as well as, total colonoscopy to the terminal ileum. The vaccinee "was initially seen by me several months ago and at that time, it appeared her diarrhea was secondary to lactose intolerance. It resolved on a lactose-free diet. However, subsequnetly, she was admitted to a hosptial 7/21/99 with complaints of chest pain. Mycardial infarction was ruled out and cardiac echo revealed a right ventricular thrombus. She also presented with an albumin of 2.5. Her diarrhea seems to have changed to what she describes as undigested food coming out intact. She does have some vague diffuse abdominal discomfort. At this point, the diarrhea is debilitating and she is contemplating quitting her job. I already placed her on high dose Pnacreane and it absolutely had no effect on her diarrhea. The two most likely causes would be malabsorption syndrome from small bowel disease or inflammatory bowel disease because of her high sed rate." colonoscopy revealed "moderately severe colitis. Severe terminal ileitis." Esophagogastroduodenoscopy revealed "erosive duodenitis at the junction between the first and second portion of hte duodenum. Diffuse chronic gastritis, normal esophagus." Biopsies taken fromt he gastric antrum, terminal ileum, right colon, transverse colon, and left colon were "consistent with chronic active IBD Crohn''s disease with involvement of hte gastric antrum and possibly first portion of the duodemun. Rectum is relatively spared." The gastroenterologist prescribed metronidazole 500mg three times daily, Asacci two tablets three times daily and ranitidine 150mg twice daily. On 10/20/99, a small bowel x-ray series with contrast revealed "moderate to severe abnormality of the distal 30 to 35cm of the ileum consistent iwth Crohn''s disease." The vaccinee returned to the gastroenterologist on 11/12/99. She "stated that she started the Omega-3, six per day, and since then all of her GI symptoms have completely resolved. She is now able to eat without any difficulty and is gaining weight. She does not want to consider taking any other medications because of the response she has had with the fish oil. Impression: Very extensive Crohn''s disease involving all areas of the GI tract except the esophagus. Recommendations: Increrase the Omega-3 to nine per day." The vaccinee was seen by the gastroenerologist on January 2000. "She is very pleased with the progress she has made since I strated her on systemic steroids and states that hse is currently enjoying the best quality of life compared to the past few years. On her own, she decided to take on herbal remedy to stimulate her immmune system. I looked this up in the PDR for herbal medicine and found that it has been reported to stimulate tissue necrosis factor, interleukin-1 and T cell mediated immunity. I explained to her that I palced her on steroids and Remicade to supress the immune system and that she should discontinue this herb. Upon physical examination, she had a markedly protuberant abdomen with hyperactive bowel sounds. Abdomen however was only mildy tender in the right lower quadrant. Impression: Severe Crohn''s disease involving stomach, ileum, and entire colon. The mildest area of inflammation was the colon and the pt is now having formed stool. I suspect that if she cntinues to heal at her current rate, the partial small bowel obstruction would resolve. She was again advised to avoid any high residue foods. Recommendations: Decrease Prednisone from 60mg to 30mg per day for one week, and then decrease to 30mg per day. Continue Asscol at six per day. Continue Metronidazele 500mg po tid. Continue Fibersco. Continue Coumadin. I gave her an txtensive literature search on the association between clotting disorders and inflammatory bowel disease. I told her that hse would be highest risk for clotting during the times of severre exacerbation. Because pt is having symptoms of feeling wired and is experiencing trouble sleeping, I prescribed Elonopin 0.5 to 1mg po bid. She was given Ativan when she was discharged form the hospital and is only taking it once per day and the effects are only lasting one to two hours." The vaccinee was hospitalized on 3/19/00 due to a small bowel obstruction. The gastroenterologist wrote: "initially the pt refused conventional therapy because of potential side effects and placed herself on Omega 3 fish oil, nine per day. She surpricingly did well for about three weeks, and then on Thanksgiving day, 1999, she called me with complaints of severe night sweats, abdominal pain and diarrhea. She was hospitlaized on the following day and treated iwth Remicade 5mg/kg IV. Within two weeks, she had a very positive response to therapy with almost total resolution of her diarrhea, abdodminal discomfort, night sweats and an increase in her overall sense of well being. She was on Metronidazole for a short time but this was discontinued because she could not tolerate the taste. I therrefore continued the Omega 3 fish oil and gave her Asacol at the usual dosage for Crohn''s colitis. She did fairly well until one month ago despite being on steroids at a farily high dose for over a month now, there has been absolutely no change in her abddominal girth, although her disease is heading toward remission except for a small area in the ileum which is causing obstruction. Since pt has 35cm of small bowel disease, I would like to avoid surgery if at all possible. I therefore recommended hospitalization, N.G.(nasogastric)suction, maximum dose IV steroids, IV Metronidazole and hyperalimentation." The gastroenterologist''s imprression was "small bowel obstruction secondary to Crohn''s disease involving hte terminal ileum." Colonoscopy perfomed on 3/31/00 revealed that the "rectum, colon and terminal ileum were all completely healed. There were only a few areas of very subtle scarring in the sigmoid colon with slight distortion of the vascular pattern, but no active Crohn''s disease. No stricture." The vacinee was seen by the gastroenterologist on 6/16/00. She reported that "she has had symptoms of arthritis involving her ankles and hands as well as edema around her ankles. Recent labs drawn by another physician showed that she has elevated transaminase. Hep B studies were consistent with prior negative, and the ferritin was normal. Bilirubin and alkaline phosphatase were not done. Pt did receive antoher dose of Remicade for treatment of the arthritis, thinking that the arthritis was an extra intestinal manifestation of the Crohn''s disease. She did notice some mild improvement post-infusion, which was two weeks ago. Impression: arthritic complaints with elevated transaminases. I suspect that this pt may have further extra intestinal manifestations of her Crohn''s disease such as sclerosing cholangitis or autoimmune hepatitis." On 7/11/00, the gastroenterolgoist wrote that Remicade "did not seem to have such benefit" with regard to the arthritic symptoms. The vaccinee "has since performed a search on the internet and found that she received a particular Lyme vaccine, which has caused reactions in multiple pts. Impression: Inflammatory bowel disease. Pt''s symptoms had their onset very shortly after she received this Lyme vaccine. I have never seen Crohn''s disease severe and extensive as hers resolve so quickly and it is also unusual for a pt who has inflammatory bowel disease in remission to experience a flare-up of arthritis. I suspect that her suspicion may be true in that she is having a serum sickness-like illness secondary to this immunization." The vaccinee was seen by a rheumatologist on 7/6/00 "in consultation for a multi-systemic autoimmune disease." At this evaluation, the vaccinee reported that she "was in excellent health until after beginning to receive her LYMErix vaccinations which were given in March 1999, April 1999 and March 2000." She reported that "in mid-April 2000 she began noticing pain and swelling in her fingers, palms of her hands, legs, soles of feet traveling to her knee. She had been given least Remicade infusion on 6/3/00 which did not help her musculoskeletal symptoms. Her GI symptoms have remained quiscent had this Remicade infusion was only given for the musculoskeletal symptpoms. She had also noticed increased stiffness. Her recent beginning of Celebrex has helped her a great deal with these symptoms. She also ntoes that she has had LFT abnormalities which a physician confirmed on transaminase elevations to approximately 100 with a negative workup thus far." On physical examination, there was "no active synovitis, no sausage digits, no psoriasis, but enthesitis in her finger tendons as well as Achilles tendons bilaterally and for a nail pit line in the same plac ein her nails of all her fingers." The rheumatologist''s impression was "her problems fall into five categories: Crohn''s disease which in presently inactive and will be treated by GI. Her enthesitis which can certainly be seen with seronegative spondyloarthropathy but she presently does not have frank arthritis. her episode of thrombosis for which she is on Coumadin. The etiology is unclear a tthis time. Her series of LYMErix vaccines. It is unclear whether this is causal either solely or as an environmental trigger. Certainly, there is a very good time relationship; however, the pt also has a family history of ulcerative colitis/inflammatory bowel disease. Perhaps molecular mimicry may be playing a role here. I have discussed with the pt that I will not be able to establish a causal or noncausal relationship but wil try to help her with the condition she has. Her LFT abnormalities." Lab analyses revealed antinuclear antibody titer of 1:320, anticardiolipin IgM titer of 1:32, aspartate aminotransferase 63, alanine aminotransferase 83, hematocrit 33%, and erythrocyte sedimentation rate 65mm/hr. HLA typing revealed HLA-B27. On 8/3/00, the rheumatologist noted that the vaccinee "believes that her Lyme vaccine is the causal element in her problems. She reports feeling better both physically and mentally. She saw an infectious disease specialist in early July who, as per the vaccinee, tested her for Lyme and told her that his results showed that she had Lyme previous to the vaccine and this is why she had these problems." The vaccinee was seen by an infectious disease specialist on 7/8/00, who noted that "from 1991 to 1995 she did research in the field on deer populations in India. She received her first Lyme injection on March 23, 1999, within a week she had problems with feeling like her legs were buckling, there was no real pain and she had some fatigue. After a second injection on 4/20/99, she developed some headaches, some confusion, some blurry eyes, fatigue became worse. She quit work, she developed SOB. She was evaluated and hospitalized for three weeks in July for an apparrent clot in her heart. She had a sedimentation rate of 120. In March of this year she developed some severe diarrhea, had evaluation and was told that she had Crohn''s disease of her bowel and her stomach. She received a third injection of Lyme vaccine on May 30th with worsening of her symptoms thereafter. She has fatigue, aches in her ankles, her shoulders, her neck, her lower back, her hips, her thighs, thumbs, MP joints of her ifngers, burning in the soles of her feet and on the palms of her hand, headaches, low grade fevers over the past year, a lot of sweating, blurriness of her eyes, some jaw and tooth pains, some twitches over the past year along with a balance problem, labored breathing, heart fluttering and pounding, urinary frequency, mentall concentration fogginess, memory issues." On physical examination, "her extremities are without edema. She has good ROM. She has slight swelling of both knees a Lyme vaccine induced reactivation of latent Lyme disease. We will start her on a therapeutic trial of Clarithromycin 500mg bid and hydroxychloroquine 200mg bid. We will do this over a three month period of time and evaluate her progress at that time." The vaccinee''s gastroenterologist prescribed physical therapy. In a letter to the gastroenterologist, dated 7/20/00, the physical therapist wrote, "Your pt came in for evaluation on 7/19/00. She has a new diagnosis with symptoms in her hands and feet. She requested tratment for these symtpoms and wanted to defer treatment of piriformis syndrome at this time. Your prescription was for treatment of piroformis syndrome. Pt decided to not proceed with evaluation until she spoke with her other physician." The vaccinee returned to the infectious disease specialist on 11/18/00. He noted that a western blot showed an IgM reaction to the 31kD protein and an IgG reaction to the 20, 23, 31, and 34 kD proteins. The reaction to the 23 and 34 kD proteins documenting prior exposure to the Lyme bacteria and the IgM reaction against the 31 kD protein consistent with ongoing active disease. She had an MRI of her brain in October that shown numerous scattered foci of what matter signals, hyperintensity involving the posterior frontal and parietal lobes, the right occipital region, medial inferior left temporal and the left brachium pontus. This is consistent with what can be seen in Lyme disease. We started her on a combination of Plaquenil and Biaxin and on this treatment she feels that she improved to about 50% of more. She is teaching again, tires easily. She is maintaining an active exercise program. She has balance problems and weakness problems, some word searching and memory issues. Visual and auditory symptomatology are 40% worse. She was a couple of rheumatologist who felt that these symptoms were nonspecific and not to be taken seriously. She does recall that in the summer of 1998 she had episodes of fatigue and urinary frequency and incontinence that were unexplained and did abate after she had the vaccine. My impression is that she is improving. We changed her over to Tetracycline 500mg tid. The vaccinee was seen by the gastroenterologist on 1/19/01. Medications included Coumadin 4.5mg daily, tetracycline 500mg three times daily, Celebrex 200mg daily, omega 3 fish oil, and Klonopin 1mg daily at bedtime. "She states that she has been haivng very severe muscle spasm involving her neck, biceps, and proximal thighs, she has been in contact with the FDA several times and they have stated that there have been approximately 1700 pts with similar problems who received the Lyme vaccine. Pt does describe having a pain down the back of her legs which tends to be worse when she is on her feet and the end of the day or in bed. She is loosing strength in both hands. Upon physical examination, pt seems to have improved compared to previous office visits. She does have severe posterior neck muscle spasm bilateraly involving the trapetius and paraspinal muscles. There is some atrophy of the thenar eminence of both hands. Grip strength is decreased bilaterally. There is tenderness to palpation over the right biceps tendon. Upon examination, I was able to reproduce the aciatica by stretching the piriformis muscle, indicating that she does have piriformis syndrome. Impression: I suspect that pt''s inflammatory bowel disease as well as her arthritic muscle problem is probably secondary to receiving Lyme vaccine. She might have had active Lyme disease at the time of the vaccination or that the Lyme disease vaccine cross-reacted to Chlamydia. She states that she has a history of having Chlamydia infection. The FDA told her that some pts with a history of Chlamydia had an adverse reaction to the vaccine. Recommendations: continue Omega 3 to prevent recurrence of inflammatory bowel disease. Referral to physical therapy for evaluation and treatment of muscle complaints. Pt will also be evaluated and treated for the piriformis syndrome." The vaccinee presented for physical therapy evaluation on 1/31/01. At that time, the vaccinee reported that she was working full time. She reported that in "May 2000 72 hrs paralyzed, falling three to four times per week-five to six times per day, fell while cycling. September-began stationary cycle, treadmill, changed jobs-multiple aches, pains, fatigue, decreased energy, memory deficits and problems with proprioception and kinesthesia." Her symptoms were relieved by rest and she went to bed nightly by 15:30. She was to undergo physical therapy twice per week for six to eight weeks. On 2/20/01, the pt stated to the physical therapist, "Those exercises are too much two times per day-I''m doing them for 1.5 hours. Pt inappropriately asking for disability rating in waiting room. Sitting and refusing PT exercises. Home exercise program only consists of stretches-never added strength to HEP. Therefore, pt performing exercises without direction." The vaccinee reported "Left UE paresthesia-relieved with proper posture." On 3/1/01, the vaccinee was discharged from physical therapy to home exercise and pool programs. The vaccinee returned to the infectious disease specialist on 2/3/01. "She has been taking Tetracycline for the last three months with no overall change as far as she can tell. She started some physical therapy, which is helping with some of her symptoms. She has gained some weight on the Tetracycline, has had a second episode of flu this month. She continues to have some pins and needles and pains in her arms, her hips are achy, continus pain in her arms, her neck and her back. With the Tetracycline she got some worsening, then some better and then some worsening. She appears to be going in streaks of one to two weeks each. Mental concentration is poor. She has had some crying, some limping. Her energy remains low. She feels that she is exhausted. Her hair has stopped falling out. My impression is that she continues to have chronic Lyme disease symptomatology. We may be turning the corner with the medication but after this next month of Tetracycline, we will change her back to the Plaquenil and Biaxin for another three to four months. I have also given her some Amantadine to try to boost the activity of the Tetracycline and to prevent or treat any influenza exposure that she has." The vaccinee was seen by a second infectious disease specialist who "is a specialist in chronic fatigue and immune disorders." In an office note dated 4/20/01, the specialist wrote, "I have been asked to evaluate the pt for Lyme disease. The pt believes that her problems began in March 1998. At that time, she was given the first shot of the Lyme vaccine. Within a few days, she was hospitalized with severe dehydration, sweats, gaastrointestinal pain, weakness and other complaints. The cause of this illness was at that time unknown. She developed some bladder control problems and was unable to exercise. In March 1999, she was given the second shot of the Lyme vaccine. Very shortly after the second shot, she was found to have a clot in her right ventricle. She was in the ICU for three weeks. After discharge from the hospital, having developed severe gastrointestinal symptoms, she was referred to a gastroenterologist. It was thought that she had Crohn''s disease. It was not thought to be typical Crohn''s however, she was treated with remicade, Asacol and prednisone. She was proposed as a candidate for GI surgery but it was noted that all of the ulceration and other GI problems had cleared. Howwever, she was left feeling very weak over the winter of 1999-2000, she had multiple hospitalizations because of the GI symptoms. She had the third shot of the Lyme vaccine in 5/00. In June, she noted that she was so weak that she was literally unable to walk. She developed a severe arthritic condition and had some elevated liver enzymes. It was also thought that she might have developed MS but this was ruled out. The pt said that she developed extremely poor special abilities such that she would reach for something and miss it or try to take a step and miss the step. She was searching for words and searching for ideas. She also noted some atrophy of the muscles in her hand. She would typically fall over when she would try to get up from a chair. She found it hard to walk and hard to do stairs. An MRI of the head showed le

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